BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 2001112 · Received February 16, 2011

    Report

    Report Number
    9681138-2011-00039
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    October 1, 2003
    Report Date
    February 15, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIGRIP (SUPER) IS MANUFACTURED IN (B)(4), AND NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER AND DESCRIBED THE OCCURRENCE OF NEURODEGENERATIVE DISORDER IN A PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (POLIGRIP) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN). AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT EXPERIENCED NEURODEGENERATIVE DISORDER, CEREBELLAR DISTURBANCE (PYRAMIDAL DISORDER AND PROBABLE DOSAL COLUMN DISTURBANCE). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2011: WHEN THE PATIENT WAS (B)(6), SHE HAD HER OWN TEETH REMOVED AND REPLACED WITH DENTURES AND FROM THAT TIME ON THE PATIENT USED GSK DENTURE ADHESIVE IN ACCORDANCE WITH THE INSTRUCTIONS. WHEN THE PATIENT WAS (B)(6), HER HEALTH DETERIORATED AND SHE WAS REFERRED TO A NUMBER OF DOCTORS IN RELATION TO THIS. ADDITIONAL INFORMATION FROM MEDICAL RECORDS RECEIVED (B)(4) 2011: THE PATIENT REPORTED EXPERIENCING PROBLEMS WALKING, INCLUDING SENSATIONS OF VERTIGO AND UNSTEADINESS, AROUND (B)(6) 2003. SHE ALSO DEVELOPED REDUCED SENSATION IN HER FEET AND A COUPLE OF MONTHS LATER, REDUCED SENSATION IN HER HANDS. INITIAL EXAMINATIONS, INCLUDING CRANIAL NERVE EXAMINATIONS AND NERVE CONDUCTION STUDIES, WERE INCONCLUSIVE, AND A HEAD SCAN (NOT SPECIFIED) IN (B)(6) 2005, SHOWED ATROPHY CONSISTENT WITH AGE. IN (B)(6) 2005, THE PATIENT WAS NOTED TO HAVE REDUCED MOBILITY AND REQUIRED THE USE OF A WHEELCHAIR. FURTHER EXAMINATIONS SHOWED NO CHIARI MALFORMATION AND AN MRI OF THE SPINE IN (B)(6) 2006, SHOWED NO SIGNIFICANT CORD INVOLVEMENT. IN (B)(6) 2006, THE PATIENT ALSO REPORTED FEELING DIZZY, GIDDY, AND UNSTEADY. IN (B)(6) 2007, THE PATIENT HAD A POSITIVE ROMBERG TEST. ON (B)(6) 2008, THE PATIENT WAS ADMITTED TO UNDERGO FURTHER TESTS. SERUM COPPER WAS 3.3 UMOL/L (NORMAL RANGE 6-9), AND SERUM ZINC WAS 24.2 UMOL/L (NORMAL RANGE 9-19). IT WAS NOTED IN HER MEDICAL RECORDS THAT HYPERZINCEMIA CAN CAUSE HYPOCUPRAEMIA, WHICH IN TURN CAN CAUSE MYELONEUROPATHY, WHICH WOULD BE IN KEEPING WITH THE PATIENT'S CLINICAL FEATURES. THE CAUSE OF THE HIGH ZINC LEVELS WAS NOT IMMEDIATELY IDENTIFIED, THOUGH THE USE OF COPPER SUPPLEMENTS WAS CONSIDERED. IN (B)(6) 2008, THE PATIENT WAS CONFIRMED TO HAVE HAD NO GASTRIC OR BOWEL DISEASE THAT COULD HAVE LED TO THIS CONDITION. IN A CONSULTANT NEUROLOGIST'S HOSPITAL LETTER DATED (B)(4) 2009, IT WAS NOTED THAT THE PATIENT HAD BEEN USING POLIGRIP FOR (B)(6) YEARS, AND DESPITE BEING ADVISED TO USE AN ALTERNATIVE DENTAL ADHESIVE, SHE WAS STILL USING POLIGRIP. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT STARTED TAKING COPPER SUPPLEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S